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KC-PROF LLC

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KC-PROF is a consultancy focused on medical device regulatory affairs, with core expertise in registration and market access in Russia and the EAEU region. We support manufacturers with a full range of regulatory services, including development of regulatory strategies, preparation and submission of registration dossiers, technical documentation review and gap analysis, product classification, risk evaluation, coordination of laboratory, preclinical and clinical studies, as well as quality management system (QMS) consulting.
Our team assists clients at every stage of the product lifecycle ‒ from early regulatory planning and market entry preparation to post-approval compliance, vigilance reporting, and ongoing post-market support, ensuring full alignment with Russian and EAEU regulatory requirements.

Company Details

Address
4 Admirala Rudneva st.
Moscow 117041

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Categories

Regulatory & Quality Control > Regulatory Compliance Consultants
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